Ajankohtaista

Bioinformatics project manager – Genevia Technologies

https://www.linkedin.com/jobs/view/3822739828

About the job

PROJECT MANAGER, COMPUTATIONAL CANCER GENOMICS (PHD)

Accepting applications for local and remote candidates! Please submit your application, including a resume and your publication list to recruitment@geneviatechnologies.com.

GENEVIA TECHNOLOGIES’ Production Team is recruiting! We are looking for an experienced bioinformatician to work in a leading role in a variety of cancer research projects for our customers in academia and industry. As a Project Manager in our Production Team, you will be:

• Planning custom state-of-the-art data analysis workflows with our clients,
• Carrying out the planned analysis, data integration, visualization and/or modeling tasks,
• Delivering publication-quality analysis results and interpretation to clients,
• Working with the client’s researchers to prepare academic publications.

YOU have plenty of experience in computational cancer genomics, such as calling, annotating, filtering and interpreting small somatic and copy-number alterations from exome and whole-genome data, and have expertise in one or more specific topics such as

• immuno-oncology (e.g., tumor microenvironment analyses, neoantigen detection, HLA typing / mutation analysis),
• clonal evolution analysis,
• cell-free DNA analysis,
• structural rearrangement analysis,
• mutational signature analysis, or
• using survival analyses and machine learning to associate molecular markers to clinical endpoints.

You also have a strong track record of publishing your work, and communicate fluently with experimental and clinical scientists on their level of understanding.

OUR CLIENTS are scientists working in research and development who use a wide variety of omics technologies, from industry standard to novel sequencing methods, to answer biomedical questions and develop biotechnology products, such as novel therapeutics. The biological applications our clients are working with range from microbiology, to plants and animals, to biomedical applications, such as immunology or cancer. You will primarily work on cancer projects.

WE APPRECIATE

• post-doctoral research experience in computational cancer genomics,
• being familiar with the analysis of a wide variety of omics data types,
• ability to implement bioinformatics workflows in bash/R/Python in an HPC environment,
• a good understanding of genetics and molecular cancer biology,
• experience collaborating with experimental and clinical scientists and publishing omics-heavy applied research papers with them,
• enthusiasm to learn new biology and technology, and
• a knack for science communication (in written text, data visualizations and conversation/presentations).

The position would be ideal for an academic bioinformatician who wants to work in a senior position in industry, but also to remain firmly within the research realm of life sciences and bioinformatics.

THE PROCESS

• Application deadline: Friday 16th of February 2024
• 1st round of interviews will take place on Monday 26th and Friday 1st of March
• 2nd round of interviews will take place on Monday 4th and Friday 8th of March
• Recruitment decisions by 15th March
• Start 1st of May with an introduction week in Finland

Please submit your application, including a resume including your publication list to recruitment@geneviatechnologies.com.

ADDITIONAL INFORMATION

For further inquiries, please contact Klaus Breitholtz at +358 40 747 7672 or klaus.breitholtz@geneviatechnologies.com.

Senior Scientist – Admescope, Oulu

https://www.linkedin.com/jobs/view/3822768145

About the job

Admescope (Symeres Finland Oy) is hiring a Senior Scientist, Drug Metabolism with strong experience in and understanding of ADME studies, for a Study Director level role.

In this position, you will be responsible for part of the studies we perform for our customers. You provide scientific support to our business development team members, plan the scientific and experimental content of the studies together with customers, provide guidance and support to laboratory technicians and scientists, draw conclusions of study results, prepare reports together with our scientists, and confirm the quality of the results and reports in your responsibility area.

You have a university degree in a suitable field of pharmaceutical sciences or chemistry, and an extensive experience and/or doctoral degree in a field related to drug metabolism research. You understand enzymes involved in drug metabolism, master liquid chromatography-mass spectrometry (LC/MS) based analytics of small molecules and are experienced in methods used to investigate metabolic clearance and identification of forming metabolites. Experience in analysis of biological drugs (oligonucleotides or antibodies) is considered as a benefit.

We offer an interesting, versatile, and challenging position in a strongly growing company with a great atmosphere, and many colleagues across our global organization. You will have an opportunity to be part of the constantly evolving drug development landscape and interact directly with the customers in support of their programs. The position is available at our site in Oulu, Finland and it is possible to work remotely part-time.

The position will be filled in winter 2024, as soon as a suitable person is identified.

Please send your application with salary request along with your CV, highlighting the relevant education and work experience to recruitment@admescope.com, with email subject line “Senior Scientist, Drug Metabolism”.

Vacancy is open for EU residents only.

Admescope is a premier ADME-Tox contract research company. Our global clientele is in the discovery and development of medicinal therapeutics, relying on our excellence in ADME sciences. Central to our success is our dedication to continuous service enhancement and seamless integration with our clients’ in-house processes, a synergy that is highly appreciated by our customers. Our commitment to excellence is reflected in our substantial investments in research and development, where we dedicate significant resources of time, funding, and expertise to stay at the forefront of innovation. The Admescope team comprises professionals including chemists, biochemists, pharmacologists, pharmacists and technicians, each possessing extensive experience and specialized knowledge in ADME studies. As part of the Symeres organization, Admescope (Symeres Finland Oy) offers comprehensive medicinal chemistry and integrated drug discovery and development services. Together, within the Symeres, we form a collective force of over 600 talented individuals across Europe and the United States.

Scientific Project Manager: CANCER GENOMICS – Genevia Technologies, Tampere

https://www.linkedin.com/jobs/view/3822731051

About the job

PROJECT MANAGER, COMPUTATIONAL CANCER GENOMICS (PHD)

Accepting applications for local and remote candidates!

Please submit your application, including a resume including your publication list to recruitment@geneviatechnologies.com.

GENEVIA TECHNOLOGIES’ Production Team is recruiting! We are looking for an experienced bioinformatician to work in a leading role in a variety of cancer research projects for our customers in academia and industry. As a Project Manager in our Production Team, you will be:

• Planning custom state-of-the-art data analysis workflows with our clients,
• Carrying out the planned analysis, data integration, visualization and/or modeling tasks,
• Delivering publication-quality analysis results and interpretation to clients,
• Working with the client’s researchers to prepare academic publications.

YOU have plenty of experience in computational cancer genomics, such as calling, annotating, filtering and interpreting small somatic and copy-number alterations from exome and whole-genome data, and have expertise in one or more specific topics such as

• immuno-oncology (e.g., tumor microenvironment analyses, neoantigen detection, HLA typing / mutation analysis),
• clonal evolution analysis,
• cell-free DNA analysis,
• structural rearrangement analysis,
• mutational signature analysis, or
• using survival analyses and machine learning to associate molecular markers to clinical endpoints.

You also have a strong track record of publishing your work, and communicate fluently with experimental and clinical scientists on their level of understanding.

OUR CLIENTS are scientists working in research and development who use a wide variety of omics technologies, from industry standard to novel sequencing methods, to answer biomedical questions and develop biotechnology products, such as novel therapeutics. The biological applications our clients are working with range from microbiology, to plants and animals, to biomedical applications, such as immunology or cancer. You will primarily work on cancer projects.

WE APPRECIATE

• post-doctoral research experience in computational cancer genomics,
• being familiar with the analysis of a wide variety of omics data types,
• ability to implement bioinformatics workflows in bash/R/Python in an HPC environment,
• a good understanding of genetics and molecular cancer biology,
• experience collaborating with experimental and clinical scientists and publishing omics-heavy applied research papers with them,
• enthusiasm to learn new biology and technology, and
• a knack for science communication (in written text, data visualizations and conversation/presentations).

The position would be ideal for an academic bioinformatician who wants to work in a senior position in industry, but also to remain firmly within the research realm of life sciences and bioinformatics.

THE PROCESS

• Application deadline: Friday 16th of February 2024
• 1st round of interviews will take place on Monday 26th and Friday 1st of March
• 2nd round of interviews will take place on Monday 4th and Friday 8th of March
• Recruitment decisions by 15th March
• Start 1st of May with an introduction week in Finland

ADDITIONAL INFORMATION

• For further inquiries, please contact Klaus Breitholtz at +358 40 747 7672 or klaus.breitholtz@geneviatechnologies.com.

Biolääketieteellisen data-analyysin tutkijatohtori – Turun yliopisto, Turku

https://duunitori.fi/tyopaikat/tyo/biolaaketieteellisen-data-analyysin-tutkijatohtori-stsur-17814705

Työpaikkakuvaus

Oletko kokenut tutkija, jolla on intohimo kehittää biolääketieteellistä data-analyysia? Liity energiseen tiimiimme Turun yliopistossa ja osallistu terveydenhuollon innovointia edistäviin huippuluokan hankkeisiin.

Apulaisprofessori Riku Klén etsii tutkimusryhmäänsä tutkijatohtoria. Tehtävä on määräaikainen 31.12.2027 saakka. Valitun hakijan toivotaan aloittavan 1.5.2024 tai sopimuksen mukaan. Tehtävä on kokoaikainen, mutta osa-aikatyö on mahdollista yhteisestä sopimuksesta.

AI4HEALTH-tutkimusryhmä tutkii biolääketieteellisen tiedon analysointia. AI4HOPE-hankkeessa hyödynnetään erilaisia tekoälyn ja koneoppimisen (AI/ML) malleja biolääketieteellisen datan analysointiin. Hankkeessa toteutetaan dementiapotilaille ja heidän hoitajilleen kehittynyt hoitosuunnitelman päätöksenteon tukijärjestelmä, joka hyödyntää multisensorista tunteiden säätelyä ja luotettavia tekoälymalleja (TAI-malleja) kivunhallintaan. Näin älykkäät teknologiat voidaan integroida onnistuneesti virtuaaliavustajiin.

AI4HOPE pyrkii erityisesti kehittämään ja parantamaan luotettavaan tekoälyyn (TAI) perustuvia digitaalisia terveydenhoitotoimenpiteitä ja -ratkaisuja kohti potilaskeskeistä hoitosuunnitelmastrategiaa dementian hoidon tukemiseksi

• kehittämällä potilaskeskeistä, tehokasta, toistettavissa olevaa ja kustannustehokasta kehittynyttä hoitosuunnittelua, jolla parannetaan potilaiden ja heidän hoitajiensa elämänlaatua;
• integroimalla helppokäyttöisiä ja kohtuuhintaisia digitaalisia terveystoimia palliatiiviseen hoitoon;
• tehokkaalla multisensorisella virtuaalitodellisuutta hyödyntävällä tunteiden säätelyllä ja kivunhallinnalla.

Tehtävänkuvaus
Tehtävään valittava henkilö työskentelee EU Horizon-tutkimusyhteistyöhankkeessa, jossa pyritään edesauttamaan terveydenhuoltoon liittyvää tietoon perustuvaa luovaa ajattelua. Tutkijatohtorin päätehtäviin kuuluu yksityisyyden suojaa turvaavan tekoälyn ja matematiikan käytännön sovellukset, kuten yhdistetty oppiminen ja synteettisen terveystiedon tuottaminen. Valitulla henkilöllä on mahdollisuus tutustua arkaluonteisen terveystiedon analysoinnin uusimpiin menetelmiin sekä testata ja kehittää näitä menetelmiä todellisilla tietokokonaisuuksilla. Hankkeet tarjoavat myös mahdollisuuksia yhteistyöhön teollisuuskumppaneiden ja muiden eurooppalaisten yhteistyökumppaneiden kanssa. Projektinhallintaan ja viestintään liittyviä tehtäviä voidaan ottaa mukaan tehtävänkuvaan hakijan omien kiinnostuksen kohteiden perusteella.

Biolääketieteellisen data-analyysin tutkijatohtorina sinulla on keskeinen rooli tutkimuksen edistämisessä. Keskeisiin tehtäviin kuuluvat:

• Monimutkaisten biolääketieteellisten tietokokonaisuuksien kehittyneen analyysin johtaminen ja toteuttaminen.
• Kehittyneiden koneoppimisalgoritmien kehittäminen ja soveltaminen.
• Yksityisyyden suojaava data-analyysi yhdistetyssä ympäristössä.
• Yhteistyö monialaisten tiimien kanssa tietoon perustuvien oivallusten integroimiseksi terveydenhuollon ratkaisuihin.
• Nuorten tutkijoiden ohjaaminen ja yhteiseen tutkimusstrategiaan osallistuminen.

Postdoctoral researcher for a Business Finland funded life science research project – University of Helsinki

https://www.linkedin.com/jobs/view/3809701218

About the job

A unique opportunity at the interface of Science Research Innovation & Business Development

We are seeking a full-time postdoctoral scientist for a Business Finland funded life science research project led by Dr. Sarah O’Keefe and Dr. Brendan Battersby at the Institute of Biotechnology, HiLIFE, University of Helsinki, Finland. The research project capitalises upon innovative technology to enhance recombinant protein synthesis in mammalian cells and to consolidate this research into a start-up biotechnology spin-out company.

Project Description

MITOGUARDER is a 2-year life science research project to commercialise our invention for enhanced recombinant protein production. As part of our scientific team, your research will contribute to the securement of intellectual property rights protections and facilitate evaluation of our innovative recombinant protein platform by 16 academic project partners across Europe and the US. You will engage with our wider team of commercialisation experts (our Commercial Champion and Helsinki Innovation Services) and our 5-member Advisory Board, gaining valuable experience in all aspects of research innovation, start-up formation and business development.

What We Offer

• A fixed term 2-year position with possible extension.
• A collaborative, innovative and inclusive group of international scientists and business experts at the leading edge of protein synthesis technology and start-up company formation.
• Cutting edge scientific and commercialisation infrastructure and technical resources.
• Unique professional and personal development opportunities (science and commercialisation).
• Rewarding long-term opportunities to join the spin-out company as a founding member to bring innovative life science technology to the market for financial gain and societal impact.
• Competitive Business Finland funded salary depending on the appointee’s qualifications and experience, 5-7 weeks of annual holiday leave, flexible hours (1612 hours/year).
• Financial support for relocation costs along with Finnish visa and residency permits.
• Occupational health care and access to high-quality sports facilities.
  
  

About You

• You are ambitious, collegial and excited to pursue life science research with commercial impact.
• You should have a PhD, or be in the final stages of PhD submission, in cell biology, protein biochemistry or molecular biology with strong communication skills and a desire to innovate.
• Knowhow in cellular protein synthesis and CRISPR/Cas9 gene editing is an advantage.
  
  

About The Institute Of Biotechnology, HiLIFE, University Of Helsinki

The Institute of Biotechnology is an independent research institute within the University of Helsinki Institute of Life Science, at the University of Helsinki, Helsinki, Finland, and at the global forefront of life science research with state-of-the-art research core facilities in genomics, biological imaging and structural biology. According to the 2024 Times Higher Education World University survey, the University of Helsinki is ranked among the top 80 universities worldwide in life science research.

How to apply?

Submit your application by clicking on the “Apply” link by 5 February 2024. Please note that your application should include a cover letter, CV, and contact details of three references. For further information on the position, please contact Dr Sarah O’Keefe(sarah.okeefe@helsinki.fi) and Dr Brendan J Battersby (brendan.battersby@helsinki.fi).

Non-clinical drug development expert – DelSiTech Oy, Turku

https://duunitori.fi/tyopaikat/tyo/delsitech-non-clinical-drug-development-expert-sdsuu-17769239

Työpaikkakuvaus

DelSiTech is the leading technology specialist in biodegradable silica-based controlled release of small molecule drugs, biopharmaceuticals and viral vectors. We focus on parenteral and local administration of drug products. DelSiTech works with its partners to turn their active agents into novel and commercially attractive therapeutic drug products and provides the technology and expertise for solving drug delivery challenges. In addition, the company is developing its own pipeline of supergeneric/505(b)(2) products to address significant unmet medical and commercial needs.

DelSiTech is growing fast and progressing in partnered and in-house development projects into non-clinical and clinical studies. We are now looking for an experienced nonclinical expert to execute and coordinate non-clinical drug development programs at DelSiTech.

Main tasks of the nonclinical drug development expert are:
– Providing non-clinical expertise for in-house and customer drug development programs
– Planning, executing and reporting of non-clinical pharmacokinetic, toxicity/safety and efficacy studies using external non-clinical service providers
– Conducting pharmacokinetic calculations in non-clinical in vivo studies
– Participation in communication with regulatory authorities as a non-clinical expert
– Participation in building a GXP quality management system in the company

We expect the applicant to have an applicable MSc or PhD degree in natural/pharmaceutical sciences and at least 5 years’ working experience in non-clinical drug development, preferably in pharma/biotech industry in a GLP environment. Previous knowledge in in-vivo pharmacokinetic calculations using relevant software is required. Understanding of non-clinical toxicity and safety studies and both in vitro/in vivo pharmacology would be valuable. Also, experience in interaction with regulatory authorities as well as non-clinical service providers both in Finland and abroad related to non-clinical development is appreciated.

We are looking for a highly motivated individual with good problem-solving capabilities and excellent reporting skills. You are able to work both as an independent professional and as a team player in multiple project teams. You are fluent in both spoken and written English.

DelSiTech offers a challenging key position with competitive salary and benefits in a dynamic drug delivery technology and drug development company. Please send your application no later than 5 February 2024, by e-mail to: info@delsitech.com

Want to know more?: Please contact Sari Häkkinen, Chief Development Officer tel. +358 44 2376 182 or sari.hakkinen@delsitech.com
Company address: Itäinen Pitkäkatu 4 C, 20520 TURKU
WWW-address: www.delsitech.com

Laboratory Technician – Radiometer, Turku

https://www.linkedin.com/jobs/view/3812708930

About the job

In our line of work, life isn’t a given – it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us – no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight – it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

R&D Function is looking for new Laboratory Technician, Assay Development.

The Laboratory Technician for Radiometer works as part of a project team, developing new immunoassay products.

This position is part of the Radiometer Turku Oy located in Turku, Finland and the position will be on-site. The position is temporary, and the estimated duration of the temporary contract is until December 2025. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Assay Development Laboratory team and report to the Laboratory Manager, Assay Development. Laboratory Technician will be responsible for planning, performing, and reporting laboratory tests and maintaining the laboratory equipment and environment.

In this role, you will have the opportunity to:

• Share knowledge and learn in an international and diverse group of highly motivated professionals, by being involved in cross-site and cross-functional collaboration
• Work in the field of medical technologies, making a difference in a company whose products can truly impact other people’s lives
• As part of Radiometer and Danaher you have many opportunities for training and career development and a wide range of staff benefits
  

The essential requirements of the job include:

• B.Sc. in Life Sciences or equivalent or other suitable laboratory education
• Knowledge on basic principles in immunoassays
• Fluency in written and in spoken English and at least basics in Finnish
  

It would be a plus if you also possess previous experience in:

• Microsoft Excel (data handling) and Microsoft Office skills.
• Continuous improvement attitude combined with good problem-solving skills.
• A background of immunochemistry and quality systems (ISO13485), as well as understanding of LEAN principles.
• We value a teammate with strong cooperative skills and positive mindset.
  

For further information, please contact Laboratory Manager, Assay Development, Hanna Silverström by e-mail hanna.silverstrom@radiometer.fi or mobile +358 40 559 4227 (By mobile best available Mon-Fri 11-11.30 AM). The recruitment will be completed as soon as a suitable candidate is found.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Laboratory Technician (Summer Work) -Radiometer, Turku

https://www.linkedin.com/jobs/view/3812711305

About the job

Meidän alallamme elämä ei ole itsestäänselvyys – se on perimmäinen tavoite. Kun elämä ottaa odottamattoman käänteen, teknologiamme ja ratkaisumme auttavat terveydenhuollon ammattilaisia tekemään tietoon perustuvia diagnostisia päätöksiä potilaan hoidon parantamiseksi. Tämä on yhteinen tavoitteemme Radiometerillä, ja se yhdistää meitä kaikkia +4000 työntekijää – riippumatta siitä, missä roolissa toimimme tai missä päin maailmaa olemme. Innovaatioiden luominen ei tapahdu yhdessä yössä – se vaatii tinkimätöntä sinnikkyyttä, intohimoa ja halua vaikuttaa. Meillä voit oppia, kasvaa ja luoda monipuolisen uran.

Radiometer on ylpeä voidessaan työskennellä Danaherin kuuden muun diagnostiikkayhtiön rinnalla. Yhdessä työskentelemme muutoksen tahdissa parantaaksemme potilaiden elämää diagnostisilla työkaluilla, joilla vastataan maailman suurimpiin terveyshaasteisiin.

QC Laboratory-tiimiin etsitään Laboranttia kesätyöhön touko-elokuun ajaksi.

QC Laboratorio vastaa laadunvarmistus-määrityksistä, immunomääritys-prosessista, sekä tuotteen vapautukseen liittyvästä testauksesta. Osaston laboranttina olet mukana suorittamassa laadunvalvontatestejä ohjeiden mukaan, raportoit laboratoriotestejä ja analysoit testituloksia ohjeiden mukaan ja osallistut tuotantotyöhön omalla alueellasi ja viet tuotantoeriä eteenpäin aikataulussa.

Tähän työhön kuuluu erilaisten laboratoriolaitteiden käyttö, laitteiden huolto ja asiakirjojen täyttö laatujärjestelmämme mukaisesti. Tulet olemaan osa QC Laboratory-tiimiä ja raportoit vastaavalle Senior Managerille.

Radiometerin visiona on parantaa maailmanlaajuista terveydenhuoltoa luotettavien, nopeiden ja helppojen potilasdiagnoosien avulla.

Työn olennaisiin vaatimuksiin kuuluu mm:

• Laborantin, laboratoriotieteiden tai muiden laboratorioalan opintojen tutkinto
• Sujuva suomen kielen taito (työohjeemme ovat suomenkielisiä)
• Perus IT-taidot
  

Olisi eduksi, jos sinulla olisi myös aiempaa kokemusta seuraavista:

• Työkokemuksen kautta hankittu osaaminen kemian tuotanto- tai kehitystyöstä, liuosten valmistuksesta, pipetoinnista, immunomäärityksistä, tavanomaisten analyysimenetelmien ja laboratoriolaitteiden käytöstä (esim. kromatografia).
• Tarkka ja vastuuntuntoinen työskentelytapa
  

Lisätietoja tehtävästä antaa rekrytoiva esihenkilö Taina Kummila-Noponen, Senior Manager, QC Laboratory taina.kummilanoponen@radiometer.fi

Täytämme paikan heti sopivan henkilön löydyttyä, joten toimithan nopeasti!

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

Projektitutkija fotosynteesitutkimukseen – Turun yliopisto

https://duunitori.fi/tyopaikat/tyo/projektitutkija-fotosynteesitutkimukseen-stsur-17780449

Työpaikkakuvaus

Meillä on avoinna paikka lahjakkaalle projektitutkijalle, joka haluaa liittyä tiimiimme ja perehtyä fotosynteesireaktioiden molekulaarisiin säätelymekanismeihin.Valittu henkilö keskittyy tutkimaan kloroplastin asetyylitransferaasi-entsyymejä ja selvittämään asetylaation vaikutusta valoreaktioiden tehokkuuden säätelyyn.Tarjoamme mahdollisuuden päästä käyttämään moderneja tutkimusmenetelmiä ja -laitteistoja fotosynteesitutkimuksen, proteiinibiokemian, molekyylibiologian ja kasvifysiologian aloilla.

Tehtävän sisältö

• tutkimusmateriaalin tuottaminen (kasvit, E.coli, Agrobakteerit
• fotosynteettisten proteiinikompleksien rakenteellinen ja toiminnallinen analyysi
• proteiinien tuottaminen ja puhdistus sekä in vitro -aktiivisuusmittaukset

Lead Specialist, Regulatory Affairs, PCS – DigitalGE Healthcare, Pohjois-Savo

https://duunitori.fi/tyopaikat/tyo/lead-specialist-regulatory-affairs-pcs-digital-sgseh-17784185

Job description

Job Description Summary In this role you will create and manage global regulatory submissions for digital products such as Software as a Medical Device (SaMD) in the GE HealthCare Patient Care Solutions business. This will include providing strategic regulatory requirements for digital product launch, premarket submissions/registrations, and post market compliance.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description Roles and Responsibilities

• Develops comprehensive regulatory strategies for digital products including SaMD (Software as a Medical Device) and Health IT applications under minimal supervision.
• Navigates evolving global regulatory requirements to facilitate and maintain market access. Assesses changes in existing products to determine the need for new / revised global licenses or registrations.
• Identifies regulatory requirements for product launch, authors premarket submissions/registrations, and performs change assessments in accordance with business timelines.
• Collaborates across the regulatory organization and cross functionally with Engineering, Clinical, and Scientific, to support global submissions in key markets.
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Manages multiple projects, effectively prioritizes regulatory deliverables, and aligns cross-functional team expectations to ensure optimal outcomes.
• Takes initiative in identifying and resolving regulatory holds, submissions issues, regulatory queries and escalates to management accordingly.

Basic Qualifications

• Bachelor’s degree in a Scientific, Engineering, Computer Science, core Life Science discipline, or a combination of training and experience demonstrating the equivalent
• Minimum of 3 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics, with a minimum of 2 years’ experience in Regulatory Affairs.
• Adept at utilizing research tools and capable of synthesizing complex information to support submissions and decision-making processes.
• Strong project management, communication, and interpersonal skills.
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, Adobe Acrobat, project management and collaboration applications.

Desired Characteristics

• Experience with Software as a Medical Device (SaMD), cybersecurity, artificial intelligence, and working knowledge of applicable standards and guidance including IMDRF SaMD framework, ISO 13485, IEC 62304, etc.
• Experience with high risk, life supporting, and life-sustaining products preferred.
• Advanced degree in scientific, technology or regulatory affairs disciplines.
• Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
• Learning oriented and eager to obtain new skills and knowledge. Demonstrates flexibility in understanding new and evolving regulations.
• Humility in understanding, but assertive when needed.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

#LI-BR3

#LI-Remote

Additional Job Description

For U.S. based positions only, the pay range for this position is $82,400.00-$123,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information
Compensation Grade

LPB2

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunities Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: Yes